|2005N-0345|| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product|
|FDA Comment Number :||EC1009|
|Submitter :||Dr. Demian Rose||Date & Time:||10/27/2005 09:10:10|
|Organization :||University of California|
| A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?|
not without severely restricting access to the "legal" population.